Presentation on endoluminal therapies: Homerton University Hospital, May 16 2011
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Presentation on endoluminal therapies: Homerton University Hospital, May 16 2011

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Wide ranging talk on Stomaphyx ROSE and Apollo Overstitch

Wide ranging talk on Stomaphyx ROSE and Apollo Overstitch

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Presentation on endoluminal therapies: Homerton University Hospital, May 16 2011 Presentation on endoluminal therapies: Homerton University Hospital, May 16 2011 Presentation Transcript

  • New Horizons in Bariatric Surgery – endoluminal treatments for weight regain after gastric bypass: Elliot R Goodman MD Bariatric Surgery Service Beth Israel Medical Center New York, NY
  • Background
    • 150,000-200,000 bariatric operations done a year
    • Weight loss of 67-75% EBWL in 80% of patients in 2 years
    • 14 year follow up study: 95% of patients maintained at least 50% EBWL
    Pories WJ, Swanson MS, MacDonald KG. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg 1995;222:339-350.
  • Background
    • Estimated 10% - 20% will regain some weight at 5 and 10 years
    • Usually a nadir weight is reached at 2 years
    • Weight regain
      • Mean 10-20% weight gain above nadir weight
      • Many patients dropping below 50% of % EBWL after primary surgery
      • >25% of RYGB patients regain almost all of their lost weight
      • Linear relationship between % weight regain and GJ stomal diameter (Dayyeh, Lautz, Thompson, 2011)
    • 12% incidence of revision after gastric bypass surgery for weight regain
  • Weight loss trajectory after gastric bypass:
  • Background
    • Review of Literature on Reoperative Bariatric Surgery
      • 838 patients - open reoperation
        • 118 major complications (14%)
        • 11 deaths (1.3%)
      • 64 patients - laparoscopic reoperation
        • 6 major complications (9%)
        • Average OR time 4.5 hours
    Jones KB. Revisional bariatric Surgery-potentially safe and effective. SOARDS 1 (2005) 599-603
  • Background:
    • 2008 ASMBS Member Survey
      • What is the weight loss expectation for an endoluminal revisional procedure
      • 76% felt 10-20% EWL at 12 months with safety equivalent to that of a therapeutic endoscopy was acceptable
      • Brethauer SA, Pryor AD, Chand B et al Endoluminal procedures for bariatric patients: expectations among bariatric surgeons (2009) Surg Obes Relat Dis Mar-Apr;5 (2): 231-6
  • Endoluminal Gastric Pouch Reduction (EGPR) StomaphyX TM
  • Endoluminal Gastric Pouch Reduction
    • StomaphyX TM (EndoGastric Solutions, Redmond WA)
      • FDA approved in the United States for endoluminal tissue approximation
      • CE marked in Europe
      • Patients who want further weight loss
      • Patients with rapid gastric emptying or dumping syndrome associated with diarrhea
  • Endoluminal Gastric Pouch Reduction
    • Procedure
      • Average 20-40 3-0 polypropylene fasteners per case
      • Start 1 cm proximal to stoma- 12-16 fasteners
      • 1-2 cm proximal to first row- another 12-16 fasteners
      • Additional fasteners until 1cm below GE junction reached
  • Diagram for fasteners H H H H H H
  • Endoluminal Gastric Pouch Reduction
  • Endoluminal Gastric Pouch Reduction Pre anastomosis Post anastomosis
  • Endoluminal Gastric Pouch Reduction Gastro-esophageal Junction
  • Fluoroscopic evidence of stomal narrowing after EGPR with Stomaphyx: GJ stoma before EGPR Stoma after EGPR
  • Serosa-to-serosa Fusion Full thickness tissue plication and serosa-to-serosa fusion seen in several animal models
  • Beth Israel Medical Center results 2008-9 (N=64) Age (years) 47.5 (24-66) Female / Male 92% female / 8% male Height (inches) 65 Median BMI Pre-Gastric Bypass 48.7 Median BMI Post-Gastric Bypass (nadir) 31.3 Median BMI Post-GB(nadir) 31.3 Median time(years) after Gastric bypass surgery 5 (2-10)
  • Median BMI before StomaphyX 39.85 (25.9-54.9) Median BMI post Stomaphyx 37.75(25.1-55.2) Median follow up(months) 6(1-13) No. Patients Weight loss 43(67%) No. Patients no weight loss 14(21%) No follow up weight available 7(12%)
  • Median weight loss (lbs.) post StomaphyX 15.5(3.3-67) Median OR time 50 (35-130) Median reduction in gastric pouch length 33%(0-67) Median # of fasteners 23(10-40)
  • RESULTS:
    • Dumping syndrome improved
    • GERD improved
  • Endoluminal Gastric Pouch Reduction
    • 3 patients underwent repeat procedure due to unsatisfactory results.
    • Maximum weight loss: 67 lbs
    • Postprandial diarrhea/GERD resolved.
        • Slowed gastric emptying
        • Obliteration of the gastrocolic reflex
        • New valve created just distal to GE junction
  • Latest data pooled from 3 large US centers (BIMC, OSU and Alvarado Hospital):
    • 124 patients underwent EGPR at three centers
    • 94% female mean age 49(+/-10)yrs mean pre-EGPR BMI 39(+/-8)
    • Mean 126lbs EWL after GB with 59lbs regained 7.1 (+/-3.7) yrs after GB
    • Followed for 6 months (+/-4 SD) after EGPR
  • Latest data (con):
    • EGPR reduced pouch length by 50(+/-24)%
    • Mean number of plications 22(+/-9)
    • Mean weight loss 25lbs – 18% EWL or 43% RWL
    • Weight loss range - 23lbs gain to 183lbs loss
  • Predictive factors:
    • Weight loss after EGPR significantly correlated with weight loss after initial GB (p=0.001)
    • Lower pre-EGPR BMI predicted better weight loss after EGPR (p=0.009)
  • Endoluminal Gastric Pouch Reduction
    • Mechanism of Weight loss
    • Reduction in size of pouch
    • Reduction in size of stoma
    • Reduce compliance of pouch
    • Slowed gastric emptying
  • The ROSE Procedure (by USGI):
  • R epair O f S urgery E ndolumenal-ROSE Repair of Dilated Gastric Pouch and Stoma Post RYGBP Dilated Stoma Post ROSE Procedure
  • ROSE with the USGI IOP Dilated pouch and stoma Stoma restoration: Use EOS to create circumferential folds around stoma Create permanent folds in pouch to reduce volume
  • ROSE Registry | Site, Patient Mix
    • 9 sites collectively enrolled 116 patients
      • Targeted cross section of users
        • Bariatric surgeons
        • Surgical endoscopists
        • Gastroenterologists
      • Targeted cross section of sites
        • Academic centers
        • Private community practices
  • ROSE Registry | Design, Demographics INCLUSION CRITERIA: Broadly defined to collect clinical experience across the full spectrum of revision patients
    • STUDY DESIGN:
    • Screening EGD to evaluate for pouch and/or stoma dilatation
    • Procedure performed under general anesthesia
    • Routine gastroscopy done pre- and post-procedure to document pouch and stoma measurements
    PATIENT DEMOGRAPHICS: AGE TIME WEIGHT ≥ 18 Years old and < 65 Years old ≥ 2 years post Roux-en-Y Bypass Achieved ≥ 50% of EWL after initial RYGB surgery 1 3 6 12 Clinical/Nutritional Follow-Up X X X X EGD Follow-Up X X Gender 101 females (87%) / 15 males (13%) Mean Age 46 years Mean BMI pre-ROSE 40
  • ROSE Registry | Safety Findings Intra-Op No significant intra-op complications
    • Early in the experience:
    • 3 patients (<3%) with mucosal esophageal tear intra-operatively
    • All resolved spontaneously within 24 hours
    Discharge Sore Throat (41%) Nausea/Vomiting (12%) 85% discharged the same day Long-Term 12 month EGDs (N=66) documented absence of stricture or ulcer
  • ROSE Registry | Acute Procedural Success PRE-PROCEDURE 2.6 cm POST-PROCEDURE 0.5 cm INTRA-OP STOMA CHANGE Cases Completed 97% (112/116) Mean Final Stomal Diameter 11.5 mm Mean % Stomal Reduction 50% Mean Final Pouch Length 3.3 cm Mean % Pouch Reduction per Case 44% Mean # Total Anchors per Case 5.9 Mean O.R. Time 87 min
  • Stoma/Pouch Reduction Achieved Cases Completed N=112/116 (97%) Mean Final Stomal Diameter 11.5 mm Mean % Stomal Reduction 50% Mean Final Pouch Length 3.3 cm Mean % Pouch Reduction per Case 44% Mean # Total Anchors per Case 5.9 Mean O.R. Time 87 min
  • Results-6 Month Weight Loss *based on target BMI 25kg/m 2 6 Month Endpoint (N=96) Mean for Total Registry Max for Individual Subject Weight Loss (kg) 6.5kg 30kg %EWL* 18% 84% % Regained Weight Lost (RWL) 32% 300%
  • ROSE WEIGHT LOSS WITH STOMA REDUCTION SUBSET 12 MONTHS N=73 (min, max) 12 MONTHS N=22 (30% of N) (final stoma <10mm) MEAN WEIGHT LOSS (LBS) 12.9 LBS 22.4 LBS MEAN % EWL (BMI25) 14 % 24 % MEAN %TBW Loss 5 % 9%
  • Grouped Variable Analysis 6 month ROSE Data Best Positive Group Predictors for %EWL at 6 months * *using linear regression modeling ¥ p<.05 statistically significant Predictive Grouping P-value ¥ %EWL from original bypass 0.0015 # of total anchors placed 0.0267 Female >50 0.0399 Pre-ROSE procedure pouch length 0.3187
  • Analysis/Discussion
    • Success post-bypass predicted ROSE success at 6 months (p=.006)
      • Top 20% RYGB pts (based on initial weight loss) lost 29% EWL at 6 months with ROSE
    • ROSE stopped weight regain in 88% (84/96) of patients at 6 months
  • Durability of Plications at 12 (and 24 Month) Endoscopy 24 month EGD post-ROSE 12 month EGDs post-ROSE
    • Anchors visible on 92% (61/66 patients) at 12 month
    • EGDs post ROSE
  • The IOP System for Revision
    • ROSE plications have been shown to be durable
    • ROSE proves to be a safe procedure
      • No major complications have occurred to date
    • % EWL after initial bypass surgery and reducing a dilated stoma to under 10mm is a valuable predictor of success with ROSE
    • Results to date begin to meet endoluminal expectations of ASMBS Technology Committee survey for revision (10-20%EWL)
      • Safety - Achieved
      • Durability - Achieved
      • % EWL @ 12 months – On Target
    • Apollo Endosurgery Overstitch System:
  • Overstitch :
    • General application endoluminal platform
    • Fits over a therapeutic upper endoscope
    • Uses 2-0/3-0 prolene or vicryl sutures
    • 144 cases performed in last 8 months – 71 pouch or stomal reductions
  • Apollo Endosurgery Overstitch pilot study for weight regain ( Thompson et al , 2011):
    • Aim: To demonstrate technical feasibility, safety and short term efficacy
    • Prospective interventional case series
    • 22 consecutive RYGB patients with weight regain and a dilated GJ stoma
  • Patient Characteristics: Average pre-bypass weight 342.2+/-75.4lbs Average nadir weight 206.23+/-57.6lbs Average weight at suturing 260.0+/-68.6lbs
  • Patient Characteristics:
    • 22 RYGB patients presented with weight regain
    Age 48+/-9 yrs Gender 16/22 (73%) female Time from RYGB 6+/-2 years Stoma diameter 25.5+/-4.3mm Pouch length 5.3+/-2.0cm
  • Technique:
    • Outlet reduction:
    • Tissue ablation (APC)
    • Interrupted stitches at the stomal margin
    • Pouch reduction:
    • Interrupted stitches in the pouch to reduce its volume
  • Results:
    • Technical success: 100%
    • Post-stomal diameter 5.6+/-1.9mm
    Outlet (n=11) Pouch (n=11) Mean procedure time 28.6+/-21.6 mins 14.8+/-9.1 mins Median sutures 3 [1-7] 2 [1-5]
  • Results: n=18 patients Average weight loss 22.5+/-13.4lbs Average follow-up time 3 months % weight regain loss 60.4% % excess weight loss 21.5%
  • Stoma vs. Pouch: Outlet reduction n=10 Outlet/pouch reduction n=8 Average weight loss 15.6lbs 30.9lbs Average follow-up time 94 days 86 days % weight regain loss 63.2% 66.1% % excess weight loss 16.7% 26.3%
  • Conclusions:
    • EGPR procedures are safe and can produce almost 50% loss of regained weight after 6-12 months
    • Long term durability still unknown
    • Pouch size reduction and stomal narrowing appears to treat dumping and GERD in most patients
    • Behavioral issues still play a major role in determining success after EGPR